Description
Description
Specifically designed for pharmaceutical and biological manufacturing, Thermo Scientific Nalgene Polycarbonate Biotainer Bottles and Carboys reduce the risk of carry-over
contamination. Durable, translucent PC construction ensures the integrity of your sample, even Frozen to -100°C.
- Provided sterile and ready-to-use; including certified clean products, which meet USP<788> standards and endotoxins below 0.5 EU/mL
- Certified clean products include triple layer packaging, with two heat-sealed layers to facilitate ease of entry into cleanrooms
Features:
- Certified clean products include triple layer packaging, with two heat-sealed layers to facilitate ease of entry into cleanrooms
- Sterile, ready-to-use products with a Sterility Assurance Level of 10-6 inside the bottle/closure
- Robust, PC can be used from -100ËšC to 100ËšC, allowing for both heated mixing and frozen storage or shipment. Must be tested in actual use conditions as results may vary depending upon application.
- Inspection procedures throughout manufacturing include leak testing, dimensional testing, visual inspection for particulates and release testing to ensure the product meets all specifications
- All container/closure systems are certified leakproof** to protect valuable contents
- Products can be supplied with forced extraction studies*, validation binders* and certificates
- Customer support includes our highly experienced commercial specialist teams, regulatory team, quality team and regional technical support
Additionally our certified clean products include:
- Clean room produced in ISO Class 7 to limit particulates during molding
- Two heat-sealed sterile barriers to protect product prior to use
- Heat-sealed bags include quick-tears on the top and bottom and placed in carton liner twisted and tape/tie sealed to prevent gross contamination on the inner packaging
- Certified and lot-to-lot tested to meet USP <788> low particulate requirements to limit potential particulate contamination
- Certified low endotoxin (0.50 EU/mL) according to USP <85> to reduce pyrogens
Dimensions:
- Closure Size: 48 mm
- Diameter: 166 mm
- Height: 299 mm
- Capacity: 5 L
- Diameter Inner Neck: 48mm
Specifications:
- Autoclavable: Not Autoclavable
- Certifications/Compliance: USP <778>, USP Class VI, non-cytotoxic, USP <661>, non-pyrogenic, FDA 21CFR 177.1315
- Closure Included: Yes
- Closure Material: Silicone-lined Polypropylene
- Graduated: Yes
- Mouth: Narrow
- Shape: Square w/ Handle
- Color: Blue-Green
- Diameter Inner Neck: 48mm
- Material: Polycarbonate
- Sterility: Sterile
- Type: Biotainer Bottles and Carboy
- Closure Color: White
Documents
Product literature
- Tech Sheet: Certified Clean Biotainer Carboys [EN]
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